Rivaroxaban

Orange BookUNIISPLATC B01AF01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerExelan pharmaceuticals,Inc

CountryUS (United States)

ATC codeB01AF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7628277418
180 TABLET, FILM COATED in 1 BOTTLE (76282-774-18)
ndc11
7628277460
60 TABLET, FILM COATED in 1 BOTTLE (76282-774-60)

Annotations

UNII (FDA Substance ID)

9NDF7JZ4M3

RIVAROXABAN

RxCUI 1114195

Orange Book

A218117

ABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9NDF7JZ4M3",
    "rxcui": "1114195",
    "inchikey": "KGFYHTZWPPHNLQ-AWEZNQCLSA-N",
    "display_name": "RIVAROXABAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "925a9a11-ae5b-405c-96d2-b1be4b85bf71": {
      "match": "brand_token",
      "title": "RIVAROXABAN TABLET, COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "15",
      "published_date": "2026-05-28"
    }
  },
  "productid": "76282-774_fcd1f593-213c-490f-b0d1-75b2d7817582",
  "productndc": "76282-774",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "218117",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Jul 31, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Jul 31, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "003",
        "approval_date": "Jul 31, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "004",
        "approval_date": "Jul 31, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIVAROXABAN",
  "proprietary_name": "Rivaroxaban",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218117",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rivaroxaban",
  "start_marketing_date": "20250804",
  "active_numerator_strength": "2.5"
}

Related drugs

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